Obstructive Sleep ApneaPhase 2ACE-Of-HEARTsNCT05616260
Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health
A Phase 2 study testing Acetazolamide and Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Acetazolamide and Continuous Positive Airway Pressure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 13 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 50 years
- Body mass index ≤ 35 kg/m2
- Untreated OSA (AHI ≥10/h)
- Abnormal blood pressure (>120/80mmHg, or on stable anti-hypertensive therapy for >1month)
Who cannot join
- Substantial sleep hypoxemia (SpO2<80% for >10% of the monitoring time during the home sleep test, or for >25% of the total sleep time during any of the in-laboratory studies)
- Severe uncontrolled hypertension (>160/110mmHg during baseline assessment; >180/120mmHg during follow up assessments)
- Abnormally low blood counts/electrolytes or renal function at baseline
- Mean use of OSA therapy ≥ 1h/night during past 1 month, or plans to urgently resume/(re)start clinical OSA therapy within 2 months
- Significant, uncontrolled cardiac, pulmonary, endocrine, renal, hepatic, neurocognitive, psychiatric, or urologic (e.g., kidney stones) disorder
- Other major sleep disorder (e.g., narcolepsy)
Show all 15Show fewer
- Urgent need to initiate effective OSA therapy (i.e., Epworth sleepiness score >18, commercial driver, prior sleep-related car accident, or based on MD judgment)
- Severe allergy to sulfa-drugs or taking another carbonic-anhydrase inhibitor (e.g., topiramate, zonisamide)
- Pregnancy/breastfeeding (current/planned)
- Prisoners
- Illicit substance abuse or >2 standard drinks of alcohol/day
- Medications that may affect OSA or ventilatory control (e.g., opiates, sedatives)
- Thiazide/loop diuretic (risk of hypokalemia)
- Inability to give consent or follow procedures
- Safety concern based on MD judgment
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego; Altman Clinical and Translational Research Institute Building
La Jolla, California, 92121
About this study
Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure increasing the risk for heart attacks and strokes. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated. Of note, especially young adults (i.e. 18 to 50 years old) benefit from treating their OSA, but they are also less likely to use the mask.
Acetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Especially young adults with OSA are likely to respond well to this drug. Further, its low cost (66¢/day) and once- daily dosing may be particularly attractive for young OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations and did not focus on young adults. The goal of this study is to test if acetazolamide can improve sleep apnea and cardiovascular health in young adults with OSA (18-50 years old), and how it does that. Thus, we will treat 46 young OSA patients with acetazolamide or placebo for 2 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 2 week period we will assess OSA severity and cardiovascular health. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide (including select individuals >50 years of age).
Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments.
Read the detailed description
The goal of this randomized, controlled, double-blind clinical trial is to compare the medication acetazolamide 500mg/day against placebo in young adults (i.e. 18 to 50 years old) who have obstructive sleep apnea and a high blood pressure. The main questions this trial aims to answer are:
- Is acetazolamide for 2 weeks more effective than placebo for treating obstructive sleep apnea?
- Is acetazolamide for 2 weeks more effective than placebo for improving cardiovascular health including blood pressure?
- What are potential predictors and mechanisms of improvements with acetazolamide in sleep apnea and cardiovascular health?
Participants will undergo the following activities:
- Eligibility screening (online or via phone; ~10min)
- Subjects who screen positive: in-person eligibility assessment (~1h) including a history, exam, blood testing, plus an overnight home sleep test
- Participants who are eligible: will come to the research lab (~15min) and be provided with a 2-week supply of the first study drug (i.e. acetazolamide or placebo) to be taken each night at home. Neither the researchers, nor the participants will know whether participants received acetazolamide or placebo. During this 2-week period, participants will wear a watch-sized activity tracker to measure their sleep amount and researchers will check in on participants weekly; at the end of the 2-week period participants are asked to wear a 24-hour blood pressure monitor and then come in for an overnight visit (~12h) which includes the following activities: general exam, questionnaires, blood test, measures of cardiovascular health (e.g. blood pressure) and neurocognitive function (e.g. a memory test), and an overnight sleep study to assess the severity of sleep apnea
- Participants will then receive a 2-week supply of the other study drug (i.e. acetazolamide or placebo) and repeat all the activities
- Optional: after completing the activities above, participants who are interested in using continuous positive airway pressure (CPAP) and are deemed good candidates for this approach by the investigators, will be offered 2-weeks of CPAP and repeat the same activities as were done when taking the study drugs (except there will be no overnight sleep study).
Researchers will compare the effects of acetazolamide on sleep apnea severity and cardiovascular health with the effects of placebo (and CPAP) to see if acetazolamide may be an effective treatment for select patients with sleep apnea.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Acetazolamide, Placebo, Continuous Positive Airway Pressure
- Keywords
- obstructive sleep apnea, OSA, CPAP, Acetazolamide
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Diamox
Acetazolamide tablet (encapsulated)
PlaceboDrug
Sugar capsule manufactured to match encapsulated Acetazolamide
Continuous Positive Airway PressureDevice
Also called CPAP
Standard CPAP device
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide, then Placebo, then optional open-label CPAP-therapy | Experimental | Subjects will start with a 2-week ACETAZOLAMIDE regimen
* Day 1-13: Acetazolamide 500mg at bedtime at home
* Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory
After a wash-out period, subjects will then cross-over to a 2-week PLACEBO regimen:
* Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home
* Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory
After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen:
- Day 1-14: CPAP will be used at home during sleep Receives: Drug: Acetazolamide; Drug: Placebo; Device: Continuous Positive Airway Pressure |
| Placebo, then Acetazolamide, then optional open-label CPAP-therapy | Experimental | Subjects will start with a 2-week PLACEBO regimen
* Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home
* Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory
After a wash-out period, subjects will then cross-over to a 2-week ACETAZOLAMIDE regimen:
* Day 1-13: Acetazolamide 500mg at bedtime at home
* Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory
After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen:
- Day 1-14: CPAP will be used at home during sleep Receives: Drug: Acetazolamide; Drug: Placebo; Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index
The AHI is a measure of sleep apnea severity and is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a >=3% desaturation or cortical arousal) per hour of sleep.
Measured: 14 days
24-hour Mean Blood Pressure
Based on 24h blood pressure measurements
Measured: 14 days
Secondary outcomes (8)
Hypoxic Burden
Respiratory event-associated area under the desaturation curve from pre-event baseline
Measured: 14 days
Reactive Hyperemia Index
Based on a device called EndoPAT, which measures non-invasively bloodflow before, during, and after 5-minutes of occlusion to one arm.
Measured: 14 days
Response Speed
Based on 10-minute Psychomotor vigilance task (PVT)
Measured: 14 days
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SDA) instrument
Based on response pattern scoring, the PROMIS 8-item SDA score will be converted into a T-score with a mean of 50 (reflecting the average for the United States general population) and a standard deviation of 10. Higher t-scores reflect greater sleep disturbance.
Measured: 14 days
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (SRI) instrument
Based on response pattern scoring, the PROMIS 8-item SRI score will be converted into a T-score with a mean of 50 (reflecting the average for the United States general population) and a standard deviation of 10. Higher t-scores reflect greater sleep-related impairment.
Measured: 14 days
Epworth Sleepiness Scale (ESS)
The ESS is an 8-item instrument assessing the likelihood of dozing off in 8 different situations with points for each item ranging from 0 to 3 (0 = would never doze off; 3 = high chance of dozing off). The points for each item are summed up, thus the total score ranges from 0 to 24, with higher ESS scores indicating greater sleepiness.
Measured: 14 days
24-hour Mean Systolic Blood Pressure
Based on 24h blood pressure measurements
Measured: 14 days
24-hour Mean Diastolic Blood Pressure
Based on 24h blood pressure measurements
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start2 Dec 2022
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, cross-over trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Schmickl, University of California, San Diego
- Investigators
- Christopher Schmickl, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616260
- Sponsor's protocol ID
- 804081
- Acronym
- ACE-Of-HEARTs
- Status last verified
- Nov 2025
- First submitted
- 7 Nov 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health
- ClinicalTrials.gov ID
- NCT05616260
- Acronym / sponsor ID
- ACE-Of-HEARTs / 804081
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, OSA, CPAP, Acetazolamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a severe type of snoring causing people to choke in their sleep. It affects millions of Americans, causing many health problems. For example, patients with OSA often feel very sleepy and are at risk of falling asleep while driving. OSA also causes elevated blood pressure increasing the risk for heart attacks and strokes. Patients with OSA are often treated with a face-mask that helps them breath at night but can be difficult to tolerate. In fact, about half the patients eventually stop using this mask. Because there are few other treatments (and no drug therapy), many OSA patients are still untreated. Of note, especially young adults (i.e. 18 to 50 years old) benefit from treating their OSA, but they are also less likely to use the mask.
Acetazolamide (a mild diuretic drug) has been used for over 50 years to treat many different conditions and is well tolerated. Recent data suggest, that acetazolamide may help OSA patients to not choke in their sleep and lower their blood pressure. Especially young adults with OSA are likely to respond well to this drug. Further, its low cost (66¢/day) and once- daily dosing may be particularly attractive for young OSA patients unable or unwilling to wear a mask each night. But previous studies had many limitations and did not focus on young adults. The goal of this study is to test if acetazolamide can improve sleep apnea and cardiovascular health in young adults with OSA (18-50 years old), and how it does that. Thus, we will treat 46 young OSA patients with acetazolamide or placebo for 2 weeks each. The order in which participants receive the drug or placebo will be randomized. At the end of each 2 week period we will assess OSA severity and cardiovascular health. Thus, this study will help assess acetazolamide's potential value for OSA treatment, and may also help to identify patients who are most likely to respond to acetazolamide (including select individuals >50 years of age).
Ultimately, this work promises a drug therapy option for millions of OSA patients who are unable to tolerate current treatments.
Detailed description
The goal of this randomized, controlled, double-blind clinical trial is to compare the medication acetazolamide 500mg/day against placebo in young adults (i.e. 18 to 50 years old) who have obstructive sleep apnea and a high blood pressure. The main questions this trial aims to answer are:
- Is acetazolamide for 2 weeks more effective than placebo for treating obstructive sleep apnea?
- Is acetazolamide for 2 weeks more effective than placebo for improving cardiovascular health including blood pressure?
- What are potential predictors and mechanisms of improvements with acetazolamide in sleep apnea and cardiovascular health?
Participants will undergo the following activities:
- Eligibility screening (online or via phone; ~10min)
- Subjects who screen positive: in-person eligibility assessment (~1h) including a history, exam, blood testing, plus an overnight home sleep test
- Participants who are eligible: will come to the research lab (~15min) and be provided with a 2-week supply of the first study drug (i.e. acetazolamide or placebo) to be taken each night at home. Neither the researchers, nor the participants will know whether participants received acetazolamide or placebo. During this 2-week period, participants will wear a watch-sized activity tracker to measure their sleep amount and researchers will check in on participants weekly; at the end of the 2-week period participants are asked to wear a 24-hour blood pressure monitor and then come in for an overnight visit (~12h) which includes the following activities: general exam, questionnaires, blood test, measures of cardiovascular health (e.g. blood pressure) and neurocognitive function (e.g. a memory test), and an overnight sleep study to assess the severity of sleep apnea
- Participants will then receive a 2-week supply of the other study drug (i.e. acetazolamide or placebo) and repeat all the activities
- Optional: after completing the activities above, participants who are interested in using continuous positive airway pressure (CPAP) and are deemed good candidates for this approach by the investigators, will be offered 2-weeks of CPAP and repeat the same activities as were done when taking the study drugs (except there will be no overnight sleep study).
Researchers will compare the effects of acetazolamide on sleep apnea severity and cardiovascular health with the effects of placebo (and CPAP) to see if acetazolamide may be an effective treatment for select patients with sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, cross-over trial.
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide, then Placebo, then optional open-label CPAP-therapy | Experimental | Drug: Acetazolamide, Drug: Placebo, Device: Continuous Positive Airway PressureSubjects will start with a 2-week ACETAZOLAMIDE regimen * Day 1-13: Acetazolamide 500mg at bedtime at home * Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory After a wash-out period, subjects will then cross-over to a 2-week PLACEBO regimen: * Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home * Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen: - Day 1-14: CPAP will be used at home during sleep |
| Placebo, then Acetazolamide, then optional open-label CPAP-therapy | Experimental | Drug: Acetazolamide, Drug: Placebo, Device: Continuous Positive Airway PressureSubjects will start with a 2-week PLACEBO regimen * Day 1-13: Placebo (matching Acetazolamide 500mg) at bedtime at home * Day 14: Placebo (matching Acetazolamide 500mg) at bedtime in the sleep laboratory After a wash-out period, subjects will then cross-over to a 2-week ACETAZOLAMIDE regimen: * Day 1-13: Acetazolamide 500mg at bedtime at home * Day 14: Acetazolamide 500mg at bedtime in the sleep laboratory After a wash-out period, subjects may then undergo an OPTIONAL, OPEN-LABEL 2-week CPAP regimen: - Day 1-14: CPAP will be used at home during sleep |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 50 years
- Body mass index ≤ 35 kg/m2
- Untreated OSA (AHI ≥10/h)
- Abnormal blood pressure (>120/80mmHg, or on stable anti-hypertensive therapy for >1month)
Key exclusion criteria (15 listed)
- Substantial sleep hypoxemia (SpO2<80% for >10% of the monitoring time during the home sleep test, or for >25% of the total sleep time during any of the in-laboratory studies)
- Severe uncontrolled hypertension (>160/110mmHg during baseline assessment; >180/120mmHg during follow up assessments)
- Abnormally low blood counts/electrolytes or renal function at baseline
- Mean use of OSA therapy ≥ 1h/night during past 1 month, or plans to urgently resume/(re)start clinical OSA therapy within 2 months
- Significant, uncontrolled cardiac, pulmonary, endocrine, renal, hepatic, neurocognitive, psychiatric, or urologic (e.g., kidney stones) disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideAlso: DiamoxAcetazolamide tablet (encapsulated) | Drug | Acetazolamide, then Placebo, then optional open-label CPAP-therapy, Placebo, then Acetazolamide, then optional open-label CPAP-therapy |
| PlaceboSugar capsule manufactured to match encapsulated Acetazolamide | Drug | Acetazolamide, then Placebo, then optional open-label CPAP-therapy, Placebo, then Acetazolamide, then optional open-label CPAP-therapy |
| Continuous Positive Airway PressureAlso: CPAPStandard CPAP device | Device | Acetazolamide, then Placebo, then optional open-label CPAP-therapy, Placebo, then Acetazolamide, then optional open-label CPAP-therapy |
Primary outcome
Apnea Hypopnea Index
Time frame: 14 days
The AHI is a measure of sleep apnea severity and is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a >=3% desaturation or cortical arousal) per hour of sleep.
24-hour Mean Blood Pressure
Time frame: 14 days
Based on 24h blood pressure measurements
8 secondary outcomes
Hypoxic Burden
Time frame: 14 days
Reactive Hyperemia Index
Time frame: 14 days
Response Speed
Time frame: 14 days
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SDA) instrument
Time frame: 14 days
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (SRI) instrument
Time frame: 14 days
Epworth Sleepiness Scale (ESS)
Time frame: 14 days
24-hour Mean Systolic Blood Pressure
Time frame: 14 days
24-hour Mean Diastolic Blood Pressure
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Schmickl, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetazolamide and Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.